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WO2018134706A1 - Mécanisme d'insertion de canules pour appareil de type patch - Google Patents

Mécanisme d'insertion de canules pour appareil de type patch Download PDF

Info

Publication number
WO2018134706A1
WO2018134706A1 PCT/IB2018/050163 IB2018050163W WO2018134706A1 WO 2018134706 A1 WO2018134706 A1 WO 2018134706A1 IB 2018050163 W IB2018050163 W IB 2018050163W WO 2018134706 A1 WO2018134706 A1 WO 2018134706A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
carriage
arm
guide
drive lever
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2018/050163
Other languages
German (de)
English (en)
Inventor
Seline STAUB
Ursina Streit
Jürg HIRSCHEL
Patrick Hostettler
Christian Schrul
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tecpharma Licensing AG
Original Assignee
Tecpharma Licensing AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tecpharma Licensing AG filed Critical Tecpharma Licensing AG
Publication of WO2018134706A1 publication Critical patent/WO2018134706A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents

Definitions

  • the invention relates to injection and infusion devices, in particular injection and infusion devices, which applied to the administration of a substance directly to the skin of the person using, in particular glued, which are also known as patch devices.
  • the invention relates to mechanisms for the insertion of cannulas, in particular so-called soft or soft cannulas, which are made for example of polytetrafluoroethylene or property-like materials.
  • An administering device for fluid products in particular an infusion pump or an injection device, in particular a patch infusion pump or a patch injector, may in principle be suitable for the administration of a wide variety of drugs, provided that the drug has a consistency with which the infusion pump or Injection device is distributable.
  • the aforementioned consistency meaning for example the viscosity, may make it reasonable to optimize the design of the injection device or the infusion pump in order to make the use of the medicament as pleasant as possible for the user.
  • patch devices patch infusion pump, especially in the treatment of diabetes with insulin, or patch injectors, especially administration of high viscosity antibody formulations.
  • the devices are stuck by means of plaster directly on the body of the user and then no longer need to be held manually or stowed for example in a holster.
  • the term "medicament” includes any fluid medical formulation suitable for controlled administration by an agent, such as an agent.
  • a cannula or hollow needle for example comprising a liquid, a solution, a gel, an emulsion or a fine suspension containing one or more medicinal agents.
  • Drug may be a single drug composition or a premixed or co-formulated multi-drug composition from a single container.
  • Drug includes drugs such as peptides (eg, insulins, insulin-containing drugs, GLP-1 containing as well as derived or analogous preparations), proteins and hormones, biologically derived or active agents, hormone or gene based drugs, nutritional formulas, enzymes, and other substances both in the art solid (suspended) or liquid form, but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable basic, auxiliary and carrier substances.
  • drugs such as peptides (eg, insulins, insulin-containing drugs, GLP-1 containing as well as derived or analogous preparations), proteins and hormones, biologically derived or active agents, hormone or gene based drugs, nutritional formulas, enzymes, and other substances both in the art solid (suspended) or liquid form, but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable basic, auxiliary and carrier substances.
  • drugs such as
  • Patch devices in the sense of the present application ie patch infusion pumps or patch injectors, often include so-called (cannula) insertion mechanisms, which serve a cannula in the tissue of the to introduce the person using it.
  • Some of these patch devices use soft infusion cannulas made of plastic, especially biocompatible fluoropolymers, for administering the fluid medicament. This has the advantage that the soft infusion cannula potentially causes less pain on movement of the surrounding tissue of the user than an infusion cannula of a rigid material such as steel.
  • Another advantage of the soft infusion cannulae is that it can not break with soft cannulas.
  • an insertion cannula (or an insertion needle) made of a rigid material such as steel is used.
  • This insertion cannula is passed through the infusion cannula prior to insertion of the infusion cannula and protrudes beyond the open end of the infusion cannula.
  • the insertion cannula is inserted into the tissue along with the infusion cannula during insertion.
  • the insertion cannula is withdrawn. Only the soft infusion cannula remains in the tissue.
  • a patch infusion pump 10 with an insertion mechanism is known, with which a soft infusion cannula 38 is introduced into the tissue with the aid of an insertion cannula 62.
  • the mechanism described uses for the insertion movement of the infusion cannula and the subsequent withdrawal of the insertion cannula separate springs 70 resp. 82, so at least one spring 70, which provides the energy for the insertion movement and at least one spring 82, which provides the energy for the return movement.
  • a patch infusion pump 100 with insertion mechanism with which a soft infusion cannula 176 is introduced into the tissue by means of an insertion cannula 174.
  • the drive of the insertion mechanism is realized with a torsion spring 181.
  • the drive spring 181 is connected to a slide 184 via an arm system 183a, 183b.
  • the two partial arms 183a and 183b are connected to each other via a hinge, so that the two partial arms 183a, 183b are rotatable in a plane relative to each other.
  • the disclosed insertion mechanism allows the execution of the insertion movement and the withdrawal movement with a spring 181.
  • distal and proximal with respect to position and direction indications are used.
  • Distal means from the point of view of the fluid path of the administering device to the person using and proximal corresponding to the reverse.
  • the movement of an infusion cannula which is introduced into the tissue of the person using it, is a movement in the distal direction, also referred to below as insertion direction.
  • One aspect of the invention includes a cannula insertion mechanism for a patch device, in particular a patch infusion pump or a patch injector.
  • insertion mechanisms for patch infusion pumps are discussed, which however can also be used in the same form for patch injectors, or could also be used in other administration devices without deviating from the invention.
  • the patch infusion pump comprises a housing.
  • the housing may be constructed in one or more parts and comprises a so-called base, which represents the region of the housing which is arranged on the skin of the user using plaster.
  • the base itself may be designed in several parts and may also include inserts, in particular guide elements, which are mounted during assembly to the base.
  • the patch infusion pump includes an insertion mechanism for placing a flexible or soft infusion cannula in tissue of the user.
  • the flexible or soft infusion cannula is introduced into the tissue with the aid of an insertion cannula.
  • the insertion mechanism of the patch infusion pump comprises a drive spring, in particular a torsion spring, and a drive or rocker arm (hereinafter called drive lever).
  • the drive lever has an axis of rotation, from which at least one arm protrudes transversely, in particular approximately perpendicular, to the axis of rotation.
  • an arm guide element is arranged, for example in the form of a cam.
  • the drive lever can be moved by energy from the drive spring in a rotational movement about its axis of rotation.
  • a spiral spring, a torsion bar or a wound on an axis and tensioned rubber band could be used as a drive spring.
  • the drive spring could be replaced by another type drive means, in particular, could be used instead of the drive spring, an electric drive to put the drive lever in the rotational movement.
  • an electric motor in particular a stepping motor, which would optionally move the drive lever via a gear and / or one or more toothed racks, could be used.
  • a transmission a worm gear would be conceivable in particular.
  • electric drives and drives are conceivable which contain piezo or shape memory elements. An advantage of an electric drive would be the simplified starting and stopping of the insertion mechanism via activation and deactivation of the electric drive.
  • the insertion mechanism of the patch infusion pump comprises a carriage to which the insertion cannula is fixed.
  • the carriage is slidably mounted on the housing, for example the base.
  • the housing comprises linear guides, for example grooves, in which guide elements of the carriage can be mounted, so that the carriage can be moved along the guides.
  • the linear guides may be straight or curved.
  • the guides dictate the insertion movement by their configuration and thus define an insertion movement axis along which the carriage can be moved.
  • the infusion cannula is drawn over the insertion cannula, which in the context of the insertion process with the aid of the insertion cannula in the tissue of the person using it is deposited.
  • the insertion cannula is withdrawn from the tissue through the infusion cannula, leaving the lumens of the two cannulas interconnected, such that the drug passes from a reservoir via a supply line and, optionally, a pumping element through the insertion cannula into the infusion cannula and into the tissue the user can be directed.
  • the insertion mechanism of the patch infusion pump comprises at least one transverse guide, in which arm guide elements of the at least one arm of the drive lever can be guided.
  • the at least one transverse guide lies in the same plane as the linear guides which define the insertion movement, or in a plane parallel thereto.
  • the transverse guides such as the linear guides on the housing, in particular the base, are fixedly arranged.
  • the transverse guides are arranged in particular on the carriage.
  • the elongated pronounced at least one transverse guide is arranged transversely to the linear guides of the housing, in particular approximately perpendicular to the linear guides.
  • the drive lever is rotatably mounted about its axis of rotation at the base of the housing, the rotation axis being approximately perpendicular to the insertion axis of movement defined by the linear guides (also located on the base) and the base.
  • the ration axis intersects the insertion movement axis.
  • the drive lever in this aspect comprises two projecting arms which have cams as arm guide elements.
  • the arms may have a 180 degree orientation on the drive lever.
  • the difference in orientation can also deviate from 180 °.
  • the carriage can be displaced relative to the drive lever along the insertion movement axis.
  • the carriage on two mutually directed away transverse guides, which have at their free ends sockets for receiving the arm guide elements.
  • the Arm entries institute can be passed through the sockets along the transverse guides after recording.
  • the transverse guides have at the free end opposite end terminations, by which a movement of the arm guide elements can be limited in the transverse guides.
  • the arm guide element of a first arm of the drive lever is in engagement with a first transverse guide on the carriage.
  • the drive spring may be disposed in this aspect of the invention with one end fixed to the base and a second end on the drive lever, so that when a torsion spring is used as a drive spring, the torque of the spring between the base and drive lever acts.
  • the drive spring causes the drive lever and thus also the two arms to rotate (about the axis of rotation of the drive lever).
  • the arm guide element of the first arm moves along the first transverse guide in the direction of the socket. Since the arm guide element describes a circular movement and moves linearly in the transverse guide, however, the transverse guide and thus also the slide must perform a compensation movement along the insertion movement axis (first partial movement).
  • the insertion needle is fixedly arranged on the carriage and thus makes the movement of the carriage with it and is displaced in the insertion direction after activation.
  • the socket Upon further rotation of the drive lever, notabene always in the same direction and driven by the drive spring, the guide of the arm guiding element of the second arm in the second transverse guide causes the carriage to start to move in the opposite direction along the insertion movement axis (second partial movement), whereby the withdrawal movement of the insertion needle begins. This movement continues until the arm guide element of the second arm reaches the conclusion of the second transverse guide. At this point, the movement is stopped and also the slide and thus the insertion cannula stand still. The insertion process is thus completed.
  • the sequence of the insertion process can be influenced in particular by the choice of the orientation of the two arms of the drive lever. It may be desired, for example, that the carriage between the two partial movements, ie the movement in the insertion direction and the retreat, stops short without the rotation of the drive lever must be stopped. If one chooses the orientations of the two arms so that before the Arm Equipmentselement of the second arm inserted through the socket in the second transverse guide, the arm guide element of the first arm has left the first transverse guide, the drive lever rotates without the carriage is moved.
  • the drive lever and the transverse guide are interchanged in the insertion mechanism. Due to the said similarity to the previous aspect, the differences are discussed here.
  • the drive lever is rotatably mounted on the carriage in this aspect and is moved with the carriage when the carriage moves along the line-shaped guides.
  • the transverse guides are brought together in this aspect to form a transverse guide, which, like the linear guides, are fixedly arranged on the base and designed, for example, as a groove.
  • the drive lever in this aspect comprises only one arm with an arm guide element at its free end, which is guided in all states of the insertion mechanism in the transverse guide.
  • the drive spring is in this aspect of the invention, for example, designed as a torsion spring, wherein a first end of the drive spring is fixedly arranged on the carriage and a second end of the drive spring fixed to the drive lever, so that stored energy can be released as relative rotation between the carriage and the drive lever ,
  • the release of energy from the drive spring causes the drive lever to rotate relative to the carriage and therefore also to the base. Since the drive lever is guided via the arm guide element in the transverse guide (linear), the carriage must compensate for the movement of the arm guide element in the transverse guide by moving along the linear guides.
  • the insertion cannula which is fixedly arranged on the carriage, is moved along the insertion movement axis, in the first part of the insertion process in the insertion direction.
  • the movement of the carriage in the direction of insertion continues until the arm of the drive lever has the same orientation as the insertion movement axis.
  • the insertion process has reached the vertex of movement, and thus the insertion cannula has reached the deepest point in the tissue of the person using it.
  • the soft infusion cannula is deposited and fixed at its proximal end so that it remains in the tissue.
  • the drive lever continues to rotate in the same direction, then the engagement of the arm guide element in the transverse guide forces a displacement of the carriage in the opposite direction. This retraction movement also moves the insertion cannula back so that it is pulled out of the user's tissue.
  • the retraction movement is limited by the proximal end of the line-shaped guides, which stops the movement of the guide elements of the carriage in the proximal direction.
  • the insertion process is complete. If the boundary were missing through the proximal end of the linear guideways, the drive lever would continue to rotate until a proximal apex was reached at which the carriage would again change direction and would be displaced in the distal direction upon further movement. The process would continue until the drive energy from the drive spring was used up.
  • FIG. 1 exploded view of the insertion mechanism of a patch pump 1 after a first
  • FIG 2 view of the parts of the patch pump shown in Figure 1 in the assembled state
  • FIG. 3 shows a plan view of the arrangement from FIG. 2
  • FIG. 4 shows a vertical section through the arrangement from FIG. 2
  • FIG. 5 horizontal section through the arrangement of Figure 2, wherein only a part of the arrangement is shown
  • FIG. 6 Detail of the cannula guide of the arrangement from FIG. 2 in vertical section
  • FIG. 12 shows an exploded view of the insertion mechanism of a patch infusion pump 100 according to a second embodiment of the invention 13 shows a view of the parts of the patch infusion pump shown in FIG. 12 in assembled form.
  • FIG. 14 Partial vertical section through the arrangement from FIG. 13
  • FIG. 15 shows a horizontal section through a region of the insertion mechanism from FIG. 13
  • FIG. 16 Detail view of the release mechanism in the initial state
  • FIG. 17 insertion mechanism from FIG. 13 immediately after release
  • FIG. 19 Insertion mechanism from FIG. 13 during insertion of the needles 103a and 103b
  • FIGS. 1 to 11c show a first embodiment of a cannula insertion mechanism according to the invention for a patch device, here by way of example for a patch infusion pump 1.
  • FIG. 1 shows an exploded view of the first embodiment. It should be noted that for reasons of clarity, the illustration does not show the entire patch infusion pump, but only the parts thereof which are important for the insertion mechanism.
  • Figure 2 shows the insertion mechanism of Figure 1 in the assembled state, which represents the initial state of the insertion mechanism.
  • FIG. 4 shows a vertical section through the arrangement of FIG. 2.
  • FIG. 5 shows a horizontal section of a section of the arrangement of FIG. 2.
  • FIG. 6 likewise shows a detail section of the arrangement from FIG the arrangement of the cannulas and the optional guide tube 3d are shown.
  • Figures 7a 11c illustrate the cannula insertion mechanism of the first embodiment of the invention in the various stages of the insertion process.
  • the patch infusion pump 1 comprises a housing 2 with a base 2a on which the insertion mechanism is constructed (see FIGS. 1 to 6), and which are designed in one or more parts, or else designed as an insert for the housing 2 can be.
  • the base 2a is adhered, for example, by means of a plaster (not shown) directly or indirectly to the skin of the person using, the patch being placed between the skin and the base 2a.
  • the patch In the region of the base, in which the infusion cannula is inserted through the skin into the tissue, the patch has an opening through which the infusion cannula can be passed.
  • the base 2a comprises four linear guides 2b which are in the form of grooves.
  • a spring holder 2c is fixedly mounted on the base 2a, the function of which will be discussed below.
  • the base 2a also includes an encoder holder 2d, on which a releaser 7 is rotatably mounted.
  • the cannula guide 2e which also comprises the insertion guide 2f, the funnel-shaped guide 2h and the optional guide tube guide 2g, is fixedly arranged on the base (see also FIG. 6).
  • the base 2a with the elements 2a to 2g can be embodied in one or more parts. In the simplest case, the base 2a with the elements 2a to 2g is designed as an injection-molded part made of plastic.
  • the cannula guide 2e may be configured as one or more additional parts made of plastic, metal or a combination of plastic or metal.
  • the linear guides 2b could also be executed skeleton-like and glued into the base, welded or snapped.
  • the insertion mechanism of the first embodiment comprises a carriage 6.
  • the carriage 6 is mounted linearly displaceably in the linear guides 2 via the guide cams 6c. So that the carriage does not get out of the guides, one or more of the guide cams 6c and complementary to one or more of the linear guides 2b can be designed snapping into each other, so that, for example, a dovetail guide can arise.
  • the carriage 6 further comprises a first guide arm 6a and a second guide arm 6b, which are oriented approximately perpendicular to the linear guides and extend approximately parallel to the base surface of the base 2a. On the upper sides of both guide arms 6a, 6b in each case a groove 6g and 6h, respectively.
  • Both grooves 6g, 6h respectively have an opening 6i at the free ends of the guide arms 6a, 6b. 6y up.
  • the carriage 6 comprises the release cam 6f, which in interaction with the releaser 7 can hold or block the insertion mechanism in the initial state.
  • the insertion cannula holder 6e is fixed, wherein the insertion cannula 3a is fixed to the insertion cannula holder 6e with its insertion cannula carrier 3c.
  • Releasably connected to the insertion cannula holder 6e is the (infusion) cannula support 9, to which the infusion cannula 3b and optionally the guide tube 3d are firmly attached (see also FIG. 6).
  • the insertion mechanism of the first embodiment comprises the cannula ensemble 3 which comprises the cannula support 9 with the cannula support base 9a. At the cannula support base 9a, the infusion cannula 3b is firmly anchored as mentioned. Furthermore, the cannula ensemble 3 comprises the insertion cannula support 3c. In the insertion cannula carrier 3, the insertion cannula 3a and the lead 3e are firmly anchored. In this case there is a fluid connection between supply line 3e and insertion cannula 3a.
  • the substance to be administered for example the liquid drug to be supplied from the reservoir (optionally via a pumping element) via the feed line of the insertion cannula.
  • the insertion cannula 3a protrudes through the lumen of the infusion cannula 3b, with the distal tip of the insertion cannula 3a protruding from the distal end of the infusion cannula 3b.
  • the insertion cannula still protrudes into the infusion cannula 3b and thus establishes the fluid connection between the inlet 3e and the infusion cannula 3b so that the substance to be administered is supplied to the person using it can be.
  • the infusion cannula 3b is movably mounted together with the cannula carrier 9 on the insertion cannula 3a, wherein in the initial state cannula carrier 9 and insertion cannula carrier 3c are firmly connected to one another via the snap arms 9b on the insertion cannula holder 6e.
  • the cannula ensemble 3 comprises the guide tube 3d, whose task is to mechanically stabilize the cannula ensemble 3 during the movement in the distal direction (see, for example, FIG. 2 or 3).
  • the guide tube 3d encloses the infusion cannula 3b.
  • the guide tube 3d has a longitudinal slot on its side facing the base 2a. If the cannula ensemble is displaced in the distal direction, the guide tube 3d is opened along the slot in the area of the cannula guide 2e and removed from the remaining cannula ensemble 3, i.
  • the infusion cannula 3b and the insertion cannula 3a are separated and not guided via the insertion guide 2f through the base 2a in the direction of tissue, but passed via the guide tube guide 2g inside the housing 2. Since the proximal end of the guide tube 3d is fixed to the cannula support 9, the guide tube 3d remains in place together with the infusion cannula, while the insertion cannula 3a is withdrawn.
  • the drive spring could also be designed for example as a helical torsion spring, coil spring, torsion bar or on an axle on rolled-up and stretched rubber band.
  • the second end of the drive spring 5 is fixedly connected to the sleeve-shaped rotation axis 4 d of the drive lever 4.
  • the sleeve-shaped rotation axis 4d is mounted concentrically with the drive spring 5 via the spring holder 2c. Energy, which is stored in the drive spring, can put the drive lever 4 in a rotation about the axis of the spring holder 2c via the arrangement described in this paragraph.
  • the drive lever 4 comprises a first arm 4a and a second arm 4b, both of which extend approximately perpendicularly away from the rotation axis 4d.
  • the cam 4e respectively.
  • 4f which may be either in engagement with the groove 6g (cam 4e) or in engagement with groove 6h (cam 4f), depending on the rotational orientation of the drive lever, which may result in a phase between the interventions (depending on the arrangement of the Arms 4a and 4b to each other), in which no cam 4e, 4f in engagement with one of the grooves 6g resp. 6h is.
  • the situation may arise that both cams 4e and 4f respectively in engagement with the groove 6g respectively. 6h (see Figure 9a).
  • the insertion mechanism of the first embodiment further comprises the releaser 7.
  • the release coupler 7 comprises the release coupler rotation axis 7a, by means of which the release coupler rotatably supports the coupler support 2d is.
  • the release device 7 comprises release arm 7b, on which the retaining cam 7c is fixed. In the initial state prevents this retaining cam 7c by engagement with the release cam 6f a movement of the carriage from the starting position addition.
  • the engagement and the particular shape of the retaining cam 7c are particularly clearly visible in FIG.
  • the retaining cam 7c is concavely formed on that surface which faces the lateral surface of the release cam 6f - matching the design of the lateral surface of the release cam 6f, which in the example in FIG. 5 is convex.
  • convex and concave surfaces could also be reversed.
  • the surfaces could have other shapes which allow stable support of the carriage 6 in at least the starting position.
  • Figures 2 to 6 show different representations of the insertion mechanism in the initial state.
  • the biased drive spring 5 causes via the rotation axis 4d of the drive lever 4, a torque and a correspondingly acting force, which from the first arm 4a the first guide arm 6a of the carriage is transmitted. Since retaining cams 7c and release cams 6f are engaged in this state, the force causes no movement.
  • FIGS. 7a and 7b show the insertion mechanism immediately after release, that is, after the retaining cam 7c and release cam 6f have been disengaged.
  • the torque causes a rotation of the drive lever 4 in a counterclockwise direction, since the carriage 6 is now movable.
  • the carriage 6 begins to move distally along the linear guides 2b, wherein also the cannula ensemble is moved with.
  • the cam 4e moves in the groove 6g in the direction of the open groove end 6i. Insertion cannula 3a and infusion cannula 3b are pushed by the movement of the carriage 6 via insertion guide 2f in the direction of the tissue of the person using.
  • Figures 9a and 9b show the insertion mechanism in the state in which the insertion cannula 3a and the infusion cannula 3b are completely inserted into the tissue (vertex of the carriage movement) after which the drive lever 4 has further rotated counterclockwise.
  • both cams 4e and 4f are in engagement with the associated grooves 6g, resp. 6h, wherein cam 4f has engaged in the groove 6h just before reaching the vertex through the open end 6j.
  • the cam 4e leaves the groove 6g through the open end 6i after reaching the vertex.
  • the direction in which the carriage 6 shifts changes as it begins to move back along the linear guides 2b, counter to the insertion direction.
  • the cannula carrier 9 is uncoupled from the insertion cannula holder 6e at the apex and fixed to the cannula guide 2e.
  • the support arms 9c of the cannula support 9 are deflected by the funnel-shaped guide 2h of the cannula guide 2e inward, so that on the one hand a connection between the support arms 9c and the cannula guide 2e and others the connection of Schnappme 9b is solved with the insertion cannula holder 6e.
  • FIGS. 10a and 10b show the insertion mechanism shortly after the withdrawal movement has started.
  • the energy stored in the drive spring is dimensioned so that residual energy is still stored after the insertion process, so that the cam 4f is actively pressed into the end of the groove 6h.
  • the illustrated first embodiment (as well as the following) of the insertion mechanism elegantly and easily permits reciprocating movement with only one rotational direction of the driving lever, making it possible to use only one spring for the insertion mechanism.
  • FIGS. 12 to 22 A further (second) embodiment of the insertion mechanism according to the invention is shown in FIGS. 12 to 22.
  • the identifiers in this embodiment were named analogously to the embodiment of Figure 1, the numbering was made such that z. B.
  • the base 2a of the embodiment of Figure 1 is analogous to the part 102a of the embodiment of Figure 12. Since the function of the embodiment from FIG. 8 is analogous or the same as that from FIG. 1, particular attention is paid in the following to the differences between the two embodiments and consequently no longer to all the details of the insertion mechanism.
  • FIG. 12 shows an exploded illustration of this alternative embodiment with the patch pump 100, wherein it should also be noted in this embodiment that the illustrations of FIGS. 12 to 22 do not show the entire patch infusion pump 100 for reasons of clarity, but only the parts of which are important for the insertion mechanism.
  • FIG. 13 shows a perspective view of the insertion mechanism of FIG. 12 in the assembled state (which corresponds to the initial state of the insertion mechanism).
  • FIG. 14 shows a vertical partial section through the arrangement from FIG. 13, wherein the drive spring has not been cut.
  • Figure 15 shows a horizontal section through a part of the arrangement of Figure 13.
  • Figure 16 shows a detail of the insertion mechanism, namely the release device with the releaser 107 in the initial state.
  • FIG. 17 shows a view of the insertion mechanism immediately after release, the releaser 107 is to be noted here.
  • Figure 18 shows the same detail as Figure 16 but now in the state immediately after release.
  • Figure 19 shows a view of the insertion mechanism in the phase in which the insertion cannula 103a is inserted together with the infusion cannula 103b in the distal direction (insertion direction) through the cannula guide 102e into the tissue of the person using it.
  • Figure 20a is a view of the insertion mechanism in the condition in which the needles 103a and 103b are fully inserted and before the insertion cannula 103a is withdrawn.
  • Figure 20b shows a partial vertical section through the insertion mechanism in the state of Figure 20a, wherein the drive spring 105 has not been cut.
  • FIG. 21 shows the insertion mechanism in the phase of insertion cannula withdrawal, i. e. the insertion cannula 103a is moved counter to the direction of insertion in the proximal direction.
  • FIG. 22 shows the insertion mechanism after completion of the entire insertion process, ie after the insertion cannula has been completely withdrawn.
  • the patch infusion pump 100 comprises a housing 102 with a base 102a. Fixed to the base 102a are the linear guides 102b, which serve to guide the movements of the carriage 106. As in the first embodiment, the cannula guide 102e is also fixed to the base. Furthermore, the base 102a comprises a further linear guide 102c which is oriented in the plane of the base 102a approximately perpendicular to the linear guides 102b.
  • the linear guides 102b as well as the linear guides 102c are channel-shaped in the example shown. Alternatively, and obvious to those skilled in the art, they could also be rail-like and project out of the surface of the base 102a.
  • the insertion mechanism of the second embodiment further comprises a carriage 106, which has the guide cam 106c, which in turn are slidably mounted in the linear guides 102b, so that the carriage 106 is displaceably mounted but secured against rotation on the base 102a.
  • the carriage further comprises the insertion cannula holder 106e, via which a fluid connection between the supply line 103e and the insertion cannula 103a of the cannula ensemble 103 is produced (for details, reference is made here to the first embodiment).
  • the carriage also includes the release arm 106f, which protrudes from the housing-like spring bearing 106d of the carriage and at the free end of a bore 106k is arranged.
  • the insertion mechanism of the second embodiment further comprises a rocking lever 104 having a rotation axis 104d and a rocking lever arm 104a at the free end of which the cams 104f and the blocking recess 104g are arranged.
  • the cam 104f is rotatably and slidably supported in the linear guide 102c in the assembled state.
  • a drive spring 105 is mounted coaxially on the rotation axis 104d.
  • One end of the drive spring 105 is firmly connected to the rocker arm 104.
  • the other end of the helical torsion spring formed as a drive spring 105 is fixedly connected to the spring bearing 106d of the carriage.
  • the rocker arm 104 is mounted on the lever bearing axis 1061 of the carriage (see Figure 14).
  • the rotational axis 104d of the oscillating lever 104 has a bore 104h, through which the lever bearing axis 1061 is guided.
  • FIG. 13 shows the insertion mechanism of the second embodiment in the initial state (further illustrations of this state are FIGS. 14 to 16). It can be seen in Figure 13 that the release arm 106f is directly above the rocker arm 104a. In this case, the release agent 107 is guided through the bore 106k and protrudes into the blocking recess 104g.
  • the drive spring 105 is biased so that a torque in the counterclockwise direction acts on the rocker arm 104a.
  • the blocking recess 104g is channel-shaped and has the stop 104i at its closed end. In the initial state, the torque now causes an engagement of stop 104i and release 107, so that rotation of the rocker arm is prevented in the initial state (see detail in Figure 16).
  • the releaser 107 is pulled out of the base 202a out of engagement with the stopper 104i (refer to FIGS. 17 and 18).
  • the rocker arm 104 can rotate relative to the carriage 106, the insertion mechanism begins to move.
  • the oscillating lever 104 now rotates counterclockwise relative to the carriage 106 (see FIG. 19), wherein the oscillating lever arm 104a of the oscillating lever 104 is displaced via the cam 104f in the linear guide 102c, at the same time the carriage 106 connected to the oscillating lever 104 via the lever bearing shaft 106I moves in the distal direction to compensate for the movement of the rocker arm 104.
  • the cannula ensemble is also moved in the distal direction, thus the insertion movement of the insertion cannula 103a and the infusion cannula 103b takes place as a result.
  • release other possibilities are known to the person skilled in the art, the release via the pin-shaped release 107 is merely to be understood as an example.
  • FIGS. 20a and 20b show the insertion mechanism with complete insertion of the insertion cannula 103a and the infusion cannula 103b but before the withdrawal of the insertion cannula.
  • the rocker arm 104 is completely below the Schlittenl 06.
  • the oscillating lever arm 104a now points in the proximal direction (see also FIG. 20b) and thereby also predetermines the maximum displacement of the carriage 106 in the distal direction, whereby the insertion depth of the cannulas is also determined.
  • cannula support 109 is coupled and fixed together with the infusion cannula 103b and the guide tube 103 to the cannula guide 102e.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un mécanisme d'insertion de canules destiné à un appareil de type patch muni d'une base et d'une glissière, sur lequel une canule d'insertion est agencée de manière fixe et sur lequel est agencé au moins un élément de guidage. Le mécanisme comprend en outre un levier d'entraînement duquel dépasse au moins un bras avec une extrémité libre, l'extrémité libre présentant un élément de guidage de bras et le levier d'entraînement étant monté à rotation sur la base ou sur la glissière. Le mécanisme comprend en outre un moyen d'entraînement pouvant accumuler et libérer de l'énergie. Le levier d'entraînement peut être déplacé, en libérant de l'énergie du moyen d'entraînement, dans un mouvement de rotation par rapport à la glissière et à la base. Sur la base est agencé au moins un tracé sur lequel vient en prise au moins un élément de guidage de la glissière, de telle sorte que la glissière soit montée de manière à être déplacée le long du tracé sans pouvoir tourner et le tracé définit le mouvement d'insertion de la canule d'insertion. Sur la base ou sur la glissière est agencée de manière fixe au moins une voie transversale d'une certaine longueur qui s'étend transversalement par rapport au tracé, l'élément de guidage de bras d'au moins un bras du levier d'entraînement pouvant être guidé dans la voie transversale.
PCT/IB2018/050163 2017-01-19 2018-01-11 Mécanisme d'insertion de canules pour appareil de type patch Ceased WO2018134706A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH00063/17 2017-01-19
CH00063/17A CH713379A2 (de) 2017-01-19 2017-01-19 Kanüleninsertionsmechanismus für ein Patch-Gerät.

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WO2018134706A1 true WO2018134706A1 (fr) 2018-07-26

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113382757A (zh) * 2018-12-20 2021-09-10 斯蒂瓦那托集团股份公司 用于递送医用流体的装置和系统以及相关递送方法

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH713378A2 (de) 2017-01-19 2018-07-31 Tecpharma Licensing Ag Kanüleninsertionsmechanismus für ein Patch-Gerät.
EP3501577A1 (fr) 2017-12-21 2019-06-26 TecPharma Licensing AG Mécanisme d'introduction de canules à aiguille

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7128727B2 (en) 2002-09-30 2006-10-31 Flaherty J Christopher Components and methods for patient infusion device
WO2013153041A2 (fr) * 2012-04-10 2013-10-17 Carebay Europe Ltd Dispositif de perfusion
US20140142508A1 (en) 2012-03-30 2014-05-22 Insulet Corporation Fluid delivery device, transcutaneous access tool and insertion mechanism for use therewith
US20150174317A1 (en) * 2013-12-19 2015-06-25 Seiko Epson Corporation Liquid transport apparatus
WO2016145094A2 (fr) * 2015-03-09 2016-09-15 Unitract Syringe Pty Ltd Mécanismes d'entraînement pour pompes d'administration de médicament

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7128727B2 (en) 2002-09-30 2006-10-31 Flaherty J Christopher Components and methods for patient infusion device
US20140142508A1 (en) 2012-03-30 2014-05-22 Insulet Corporation Fluid delivery device, transcutaneous access tool and insertion mechanism for use therewith
WO2013153041A2 (fr) * 2012-04-10 2013-10-17 Carebay Europe Ltd Dispositif de perfusion
US20150174317A1 (en) * 2013-12-19 2015-06-25 Seiko Epson Corporation Liquid transport apparatus
WO2016145094A2 (fr) * 2015-03-09 2016-09-15 Unitract Syringe Pty Ltd Mécanismes d'entraînement pour pompes d'administration de médicament

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113382757A (zh) * 2018-12-20 2021-09-10 斯蒂瓦那托集团股份公司 用于递送医用流体的装置和系统以及相关递送方法
CN113382757B (zh) * 2018-12-20 2023-07-25 斯蒂瓦那托集团股份公司 用于递送医用流体的装置和系统以及相关递送方法

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